RightFit
RecruitingPhase 1 / Phase 2

Psilocybin to Treat Depression in Spinal Cord Injury

Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 16 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "There will be at least 16 study visits, including medical and mental health check-ups, psilocybin assisted therapy, primary study endpoint and follow-up visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg). The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses. Participants will: * Agree to be enrolled in the study for up to 13 months. * Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy. * Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits. * Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Able and willing to provide informed consent * Spinal cord injury for at least 1 year * Confirmed diagnosis of depression * At least 22 years of age at time of consent * At least 50 kg (110 lbs.) body weight * Fully independent from ventilatory support (ventilator or diaphragm pacer) * Fluent in speaking and reading English * Able to swallow pills * Agree to have study visits recorded with audio and video * Agree to release outside medical and psychiatric records * Able and willing to taper off antidepressant, under clinician supervision * Agree to use adequate contraceptive methods Exclusion Criteria: * Are not able to give adequate informed consent * Have used psilocybin or another psychedelic within 6 months * Have received Electroconvulsive Therapy (ECT) within 12 weeks * Have used ketamine within 12 weeks * Have a history of Bipolar I Disorder * Have a current eating disorder * Have a current severe alcohol or cannabis use disorder within the 6 months * Have an illicit drug or prescription drug substance use disorder within 12 months * Current serious suicide risk * History of heart attack, aneurysm, or stroke * Uncontrolled hypertension * Are pregnant or nursing

Study sites (1)

NY